KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD— 510(k) K920809

Name: FDA 510(k) clearance K920809
Creator: U.S. Food and Drug Administration
Published: 1992-04-17

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K920809 for KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD, Substantially Equivalent on 1992-04-17. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1992-02-21
Decision date: 1992-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIS

view all

K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR2012-08-14
K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR2006-05-31
K060266 — DIMENSION IRON CALIBRATOR2006-03-09
K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR2005-12-23
K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)2003-11-07

More clearances from King Diagnostics, Inc.

view all

K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT1993-10-22
K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED1993-08-25
K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)1993-08-16
K931326 — KING DIAGNOSTICS CK REAGENT1993-06-15
K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT1992-11-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.